Concomitant medical product: product id 2ach20 mapping catheter (unknown serial/lot); product id 900304 (unknown serial/lot); product type: transseptal dilator/needle flexcath cross product event summary: data files were returned and analyzed.One patient file was received and recorded on the reported date of the event.The patient file showed 12 applications were performed with the balloon catheter with lot unknown on the reported date of the event.The patient file did not show any system notice on the reported date of the event.The console output data (pressure, preset pressure, and flow) showed pressure was tracking, and preset pressure and flow readings were as expected.The temperature profile was unexpected during ablation at application number 11.In conclusion, the reported clinical issue (stroke) cannot be assessed through data analysis.The balloon catheter was discarded and was not returned for analysis.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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It was reported that the day after a cryo ablation procedure, the patient showed symptoms of a stroke.It was noted that a transeso phageal echocardiogram (tee) was performed prior to the case due to the patient's noncompliance with anticoagulant therapy.The tee was clear per the physician.The patient spent "an extra day or two in the hospital." no intervention was needed, and the physician expects the patient to fully recover with time.The case was completed with cryo with no known issues.No further patient complications have been reported as a result of this event.
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